Recall Register

Innovasis, Inc: FDA recalls

FDA enforcement events from 2014 to 2026; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Innovasis, Inc as the recalling firm in 7 events. The events have 7 product records. The recalls started from 2014 to 2026. All the events are device recalls. By FDA enforcement events, Innovasis, Inc is number 506 of 1,628 firms that have a page. Events that Innovasis, Inc started: 1 in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 100.0% of its events and 73.7% of all FDA events.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

7 events, newest first.

FDA enforcement events of Innovasis, Inc
InitiatedProduct (first record)TypeClassRecordsStatus
22 May 2026Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw SystemDeviceClass II1Ongoing
14 Aug 2024TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in…DeviceClass II1Ongoing
7 Apr 2020Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.DeviceClass II1Terminated
8 Jan 2018Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:DeviceClass II1Terminated
5 May 2017Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of…DeviceClass II1Terminated
7 Dec 2015Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.DeviceClass II1Terminated
7 Jul 2014Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Innovasis, Inc: events for each product type
TypeEvents
Device7
Innovasis, Inc: events in each class
ClassEvents
Class II7
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
2

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Innovasis, Inc, by the year that the recall started. The largest year is 2014, with 1 event.

Official channels

Cite this page

Recall Register. Innovasis, Inc: FDA recalls. https://recallregister.com/firm/innovasis-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
3 Nov 2026
State of the firm address
UT

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Innovasis, Inc have?
Class II: 7 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Innovasis, Inc?
FDA event 99188, which the firm started on 22 May 2026. The first product in the record is: Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
How many FDA recalls of Innovasis, Inc have the status Ongoing?
2 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.